Stakeholder Opinions: Nosocomial Infections - The need for new gram-negative drugs

Published by: Datamonitor

Published: Mar. 22, 2007 - 162 Pages

Table of Contents

ABOUT DATAMONITOR HEALTHCARE

About the Infectious Diseases and Respiratory (ID&R) pharmaceutical analysis team

CHAPTER 1 EXECUTIVE SUMMARY

Scope of the analysis

Datamonitor insight into the nosocomial infections market

CHAPTER 2 DISEASE BACKGROUND

Disease definition

Epidemiology

Modes of acquisition

Surgical site infections

Causative pathogens

General incidence

Pathogenesis

Bloodstream infections

Causative pathogens

General incidence

Intravascular catheter-related infections account for the majority of BSIs

Pathogenesis

Urinary tract infections

Causative pathogens

General Incidence

The majority of hospital acquired UTIs are associated with contaminated urinary catheters

Pathogenesis

Pneumonia

Causative pathogens

General incidence

Mechanical ventilation increases the risk of HAP

Pathogenesis

CHAPTER 3 ETIOLOGIC AGENTS

Bacterial pathogens

Bacterial resistance

Gram-positive bacteria

Staphylococcus aureus

Enterococci

Clostridium difficile

Gram-negative bacteria

Escherichia coli

Klebsiella pneumoniae

Pseudomonas aeruginosa

Acinetobacter baumannii

Viral pathogens

Fungal pathogens

CHAPTER 4 TREATMENT OPTIONS

Hospital antibacterial market

The overall value in terms of patient numbers

Size of the market in terms of sales

Classes of antibacterials

Cephalosporins

Penicillins

Fluoroquinolones

Carbapenems

Macrolides and ketolides

Glycopeptides

Empiric management of nosocomial infections

Cost of therapy by site of infection

Surgical site infections

Antibiotic prophylaxis prior to surgical operations

Post-operative treatment

Bloodstream infections

Urinary tract infections

Hospital acquired pneumonia

Pathogen specific therapy

Gram-positive pathogens

Staphylococcus aureus (including MRSA)

Enterococci

Clostridium difficile

Gram-negative pathogens

Klebsiella pneumoniae

Pseudomonas aeruginosa

Acinetobacter baumannii

Factors influencing physician decision-making

CHAPTER 5 FUTURE TRENDS AND IMPROVING TREATMENT OUTCOMES

New product development

Effective gram-negative drugs is the greatest unmet need

The financial burden of multidrug-resistant gram-negative organisms

Majority of newly introduced compounds and compounds in late-stage development target gram-positive pathogens

Tigecycline

Daptomycin

Dalbavancin

Telavancin

Doripenem

Ceftobiprole

Preventative strategies to help combat spread of infections in hospitals

Surveillance

Combating bacterial resistance

Financial burden of nosocomial infections

BIBLIOGRAPHY

Books

Press releases

Websites

Datamonitor reports

Contributing experts

Disclaimer

List of Tables

Table 1: Most common pathogens isolated from hospital acquired bloodstream infections, US

Table 2: Incidence rates and distribution of pathogens most commonly isolated from monomicrobial bloodstream infections and associated crude mortality rates for all patients, patients in intensive care units (ICUs) and patients in non-ICU wards

Table 3: Staphylococcus aureus-related discharge diagnoses in the US by patient age and infection site, 1999-2000

Table 4: The number of invasive S. aureus (SAU) isolates and the proportion resistant to methicillin in the five major EU markets, 2005

Table 5: Prolonged stay and mortality rate from Acinetobacter infections in the US

Table 6: Overall cost of therapy in the US by site of infection

Table 7: Overview of recently launched antibacterials and antibacterials in late stage development, 2007

List of Figures

Figure 1: The four major types of nosocomial infections

Figure 2: Percentage of four main types of nosocomial infections of all nosocomial infections

Figure 3: Endogenous and exogenous routes of acquisition

Figure 4: Infections associated with invasive devices and procedures

Figure 5: Types of Surgical Site Infections (SSI)

Figure 6: Diagrammatic representation of types of SSI

Figure 7: Incidence density (/1000 patient days) of registered SSI by surgical procedure (overall) and 95% confidence intervals

Figure 8: Incidence density (overall) mean of registered surgical site infection by NNIS risk index and by surgical procedure

Figure 9: Cumulative incidence of SSI in hospitals in England and Wales, 1997-2005

Figure 10: Adjusted SSI rates,1997-2005

Figure 11: Definition of Bloodstream infection (BSI)

Figure 12: Incidence rates and distribution of pathogens most commonly isolated from monomicrobial bloodstream infections and associated crude mortality rates for all patients, patients in intensive care units (ICUs) and patients in non-ICU wards

Figure 13: Estimated number of deaths caused by nosocomial BSIs each year in the US, 2001

Figure 14: Mean rates of BSI across ICUs in NNIS hospitals, 2004

Figure 15: The urinary tract

Figure 16: Mean rate of UTI per 1000 urinary catheter days in NNIS hospitals, 2004

Figure 17: Classification of Urinary Tract Infections (UTI)

Figure 18: Classification of Hospital-acquired pneumonia

Figure 19: Mean rate of VAP per 1000 ventilator-days in NNIS hospitals, 2004

Figure 20: Endotracheal intubation

Figure 21: Distribution of outbreaks of hospital infections by pathogen, 1997-2002

Figure 22: Gram-negative and gram-positive bacteria

Figure 23: Distribution of type of bacteria in hospital infections

Figure 24: Percentages of gram-negative and gram-positive organisms by site of infection from 1986-2003

Figure 25: Selected antimicrobial-resistant pathogens associated with nosocomial infections in ICU hospitals, comparison of resistance rates from January-December 2003 with rates for 1998-2002

Figure 26: Methicillin (oxacillin)-resistant Staphylococcus aureus (MRSA) among ICU patients, 1995-2004

Figure 27: Staphylococcus aureus: proportion of invasive isolates resistant to oxacillin (MRSA) in Europe, 2005

Figure 28: Staphylococcus aureus: trends of methicillin-resistance by European country, 1999-2005

Figure 29: Vancomycin-resistant Enterococci among ICU patients in the US, 1995-2004

Figure 30: Proportion of invasive Enterococcus faecalis isolates resistant to aminoglycosides in Europe, 2005

Figure 31: Proportion of invasive Enterococcus faecium isolates resistant to vancomycin in Europe, 2005

Figure 32: National estimates of US short-stay hospital discharges with Clostridium difficile listed as primary or as any diagnosis, 1996-2003

Figure 33: C. difficile reports from patients aged years and over, received under the mandatory reporting scheme in England during 2004 and 2005

Figure 34: US states with the NAP1 strain C. difficile confirmed by the CDC as of September 2006

Figure 35: Escherichia coli: trends of amino-penicillin- and fluoroquinolone-resistance by European country, 1999-2005

Figure 36: Third generation cephalosporin-resistant Klebsiella pneumoniae among ICU patients in NNIS participating hospitals in the US,1995-2004

Figure 37: Proportion of invasive Klebsiella pneumoniae isolates resistant to 3rd generation cephalosporins, carbapenems, fluoroquinolones and aminoglycosides in Europe, 2005

Figure 38: Fluoroquinolone-resistant Pseudomonas aeruginosa among ICU patients in the US, 1995-2004

Figure 39: Proportion of invasive Pseudomonas aeruginosa isolates resistant to carbapenems, ceftazidime, fluoroquinolones and aminoglycosides in Europe, 2005

Figure 40: Total number of patients developing nosocomial infections in an average year in the US

Figure 41: Antibacterial sales across the seven major markets by sales and volume, 2001-05

Figure 42: Sales and volume use in the hospital versus the community market, excluding Japan, 2001-05

Figure 43: Sales of hospital antibacterials in the six major markets, excluding Japan, 2005

Figure 44: Percentage share of overall hospital antibacterial sales by class in the six major markets, excluding Japan, 2005

Figure 45: Cost of antibiotic therapy per patient by site of infection (US average wholesale prices)

Figure 46: Share of each type of infection of overall expenditure on antibacterials to treat nosocomial infections, US

Figure 47: Summary of management strategies for patients with suspected HAP, VAP and HCAP

Figure 48: Empiric management of HAP, HCAP, VAP

Figure 49: Initial antibiotic therapy for patients with no known risk factors for multidrug resistant pathogens, early onset and any disease severity

Figure 50: Initial therapy for hospital-acquired pneumonia in patients with late-onset disease or risk factors for multidrug resistant pathogens and all disease severity

Figure 51: Initial intravenous adult doses of antibiotics for empiric therapy of HAP, HCAP and VAP in patients with late-onset disease or risk factors for multidrug-resistant pathogens

Figure 52: Treatment options for CDAD

Figure 53: Summary of the factors influencing prescription choice from KOL research

Figure 54: Patient stratification by risk factors

Figure 55: Prevention strategies by risk factor

Figure 56: Antibiotic resistance: a vicious cycle

Figure 57: A schematic representation of the costs associated with HAI

Abstract

Introduction

In the US and Europe, an estimated 5-10% of patients are expected to develop an infection during their hospital stay. The four main types of infections that occur within the hospital setting are urinary tract infections, hospital acquired pneumonia, surgical site infections and blood-stream infections, accounting for approximately 35%, 15%, 14% and 10% respectively.

Scope

• Overview of the epidemiological trends of the four main types of nosocomial infections.
• An analysis of the incidence and antimicrobial susceptibilities of etiologic agents.
• An estimation of the current antibiotic treatment costs and market size by infection site.
• An assessment of key unmet needs and new product development

Highlights

Over the past decades, there has been a notable rise in the number of hospital infections caused by gram-positive bacteria such as Staphylococcus aureus and enterococci. However, the most important observation has been that of the rising numbers of gram positive bacteria resistant to several of the currently available antibiotics. Although gram-positive organisms account for the majority of nosocomial infections, there has been a big increase in multi-drug resistant gram-negative bacteria such as extended-spectrum beta-lactamase (ESBL) producing E. coli and K. pneumoniae and strains of P. aeruginosa and A. baumannii resistant to all currently available antimicrobials. The majority of newly introduced products and products in late stage development target gram-positive bacteria such as MRSA. Although these agents have been welcomed by the infectious disease community, Datamonitor believes there is a significant opportunity for new antibacterials which can treat multi-drug resistant gram-negative organisms.

Reasons to Purchase

• Identify the key factors that determine treatment choice in nosocomial infections.
• Examine the remaining and emerging unmet needs in the nosocomial infections market and identify opportunities for new product development.
• Gain an overview of market size and treatment cost of the four most common infections in terms of value and patient numbers

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